FDA approves skin infection drug

May 28, 2014

The Food and Drug Administration has approved an antibacterial medication for the treatment of adult patients with acute skin infections.

The Food and Drug Administration has approved an antibacterial medication for the treatment of adult patients with acute skin infections.

Dalvance (dalbavancin, Durata Therapeutics) is an intravenous drug for the treatment of acute bacterial skin and skin structure infections caused by bacteria such as Staphylococcus aureus - including methicillin-resistant and methicillin-susceptible strains - and Streptococcus pyogenes.

“Dalvance’s unique dosage regimen offers a new approach to treatment of these serious skin infections by allowing patients, healthcare professionals and hospitals to move beyond the standard daily or twice-daily IV antibiotic infusions,” Paul Edick, Durata CEO, said in a news release.

Next: Safety and efficacy assessment

 

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Dalvance became the first medication designated as a qualified infectious disease product (QIPD) to be given FDA approval, the FDA noted in a statement. The drug was given the designation because it qualifies as an antibacterial or antifungal medication intended for the treatment of serious or life-threatening infections.

The safety and efficacy of Dalvance were assessed in two clinical trials of 1,289 adult patients with acute bacterial skin and skin structure infections (ABSSSI). Patients were randomly assigned to treatment with Dalvance or the antibacterial drug vancomycin. Dalvance was found to be as effective as vancomycin, the FDA reports.

Dalvance is approved for treatment of ABSSSI with a two-dose regimen of 1,000 mg followed one week afterward by 500 mg, each administered over 30 minutes, the company states.

More on MRSA

Drug-resistant diseases re-emerge, gain strength 

Which hand sanitizers are most practical and effective?

Skin microbiome, immune system interact to maintain skin health